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EMA pilot will see if clinical trial data should be digested ‘raw’

pharmaphorum

It has been quick to give reassurance that any analysis of patient data will comply with the EU’s data protection requirements. “Access to raw data can assist regulators in understanding the submitted evidence and therefore inform the regulatory decisions on the benefit-risk balance of the product,” it continues.

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Synthetic control arms in clinical trials: Making it happen

pharmaphorum

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. David Clifton is professor of clinical machine learning in the Department of Engineering Science of the University of Oxford. About the panel.

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5 Top Emerging Pharmacovigilance Startups Impacting The Industry

Cloudbyz

Time is also of the essence in drug development, as competitive product-to-market lead times help pharma companies improve profitability. Time spent on clinical trials involves investment and being able to predict ADRs assists with improving the success rate. Navro Technology Solutions – AI-Based Pharmacovigilance.

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Creating an effective patient engagement set of practices that is enduring and future-proof

pharmaphorum

For the past ten years we’ve seen a steady acceptance of the need for patient engagement practises to become routine and integrated into all systems of healthcare and the creation of new medicines and devices. Patients are beginning to expect the providers of their medicines to help them with their condition and the impact on their lives.